nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4,8 and 16 compared to baseline. Measurements at baseline and week 16 are used to calculate estimates for changes and differences between the groups. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ICMJE (submitted: July 20, 2006)

week 16 are used to calculate estimates for changes and differences between the groups.

The safety and tolerability of Epo in combination with Mpred in subjects with optic

neuritis/MS is a primary interest of this study. Additionally, an objective of primary interest is

to calculate an estimate for the efficacy of this therapy with respect to nerve fiber loss in the

optical nerve head after an episode of acute optic neuritis. Nerve fiber loss will be measured

by OCT using the change in retinal nerve fiber layer thickness around the optical nerve head

and the change of neural tissue volume in the optical nerve head itself. The measurements will

be performed at baseline, week 4, week 8, and week 16. The measurements at baseline and

performed at weeks 4, 8, and 16 and will be compared to baseline (week 0).

Recovery of latency and amplitude of visual evoked potentials (VEPs).

Electrophysiological measurements will be performed at weeks 4, 8, and 16, and will

be compared to baseline (week 0).

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Safety and Efficacy Study of Erythropoietin as add-on Therapy of Methylprednisolone to Treat Acute Optic Neuritis

Official Title ICMJE

Double Blind, Placebo-controlled Study to Determine the Safety and Efficacy of Erythropoietin as an add-on Therapy of Methylprednisolone in Subjects With Acute Optic Neuritis (VISION PROTECT)

Brief Summary

The purpose of this study is to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis.

Detailed Description

SUMMARY This study is a multicenter, double-blind, placebo-controlled, parallel-group study to determine the safety and efficacy of erythropoietin (Epo) as an add-on therapy to methylprednisolone (Mpred) in subjects with acute autoimmune optic neuritis.

The primary study endpoint is nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4, 8, and 16 compared to baseline.

A number of 40 subjects will be randomized in equal numbers into one of the two treatment groups.

Treatment groups:

Epo or placebo will be administered i.v. at three consecutive days. Epo or placebo is to be given once daily following application of Mpred preferably between 8 and 10 a.m..

Subjects will be randomized to one of the following two treatment groups and dosed as follows:

Mpred at a dose of 1000 mg per day on days 1 - 3 given as an i.v. infusion AND 3.3 x 10^4 IU recombinant human Epo per day on days 1- 3 given as an i.v. bolus injection.

Mpred at a dose of 1000 mg per day on days 1 - 3 given as an i.v. infusion AND placebo (normal saline) on days 1 - 3 given as an i.v. bolus injection.

Men and women between the ages of 18 and 50, inclusive, diagnosed with acute unilateral optic neuritis with or without prior diagnosis of multiple sclerosis (according to McDonald criteria; Polman et al., 2005) will be considered for inclusion into the study. Those subjects must have a decreased visual acuity on the affected eye to 0.5 or less and must have signed written informed consent. While safety will be monitored during the study, an efficacy evaluation will be done after all subjects have completed week 16.

Each subject included in the study will be seen by a treating neurologist and an examining neurologist as well as by an examining ophthalmologist. The treating neurologist will function as the primary treating physician and conduct all subject safety assessments. The examining ophthalmologist and the examining neurologist will conduct all evaluations of vision/optical nerve head atrophy and neurological symptoms, respectively, but will not be involved in any other aspect of patient care. A neurophysiologist will perform measurements of VEPs. MRIs will be performed by a neuroradiologist.

Treatment with corticosteroids or Epo within 30 days prior to randomization. Miscellaneous

Female subjects considering becoming pregnant while in the study.

Female subjects who are currently pregnant or breast-feeding.

Previous participation in this study or any other investigational drug study within the last four weeks.

Current enrollment in any other investigational drug study.

Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.

Any other reasons that, in the opinion of the investigator, the subject is determined to be unsuitable for enrollment in this study.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects